Cleared Traditional

K211940 - Fetal Doppler (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211940 · Shenzhen Taikang Medical Equipment Co., Ltd. · Obstetrics & Gynecology device
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Jan 2022
Decision
198d
Days
Class 2
Risk

K211940 is an FDA 510(k) clearance for the Fetal Doppler. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Shenzhen Taikang Medical Equipment Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 7, 2022 after a review of 198 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2660 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Taikang Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K211940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2021
Decision Date January 07, 2022
Days to Decision 198 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 160d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNG Monitor, Ultrasonic, Fetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - KNG Monitor, Ultrasonic, Fetal

All 59
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K211940.
Fetal Doppler U8-25, U9-25
K252669 · Zhongshan Xiaolan Town Senlan Electronic Factory · Jan 2026
Doppler FHR Detector (BF-500D+, BF-560)
K242846 · Shenzhen Bestman Instrument Co., Ltd. · Jun 2025
Ultrasonic Fetal Doppler
K233823 · Shenzhen Jamr Technology Co., Ltd. · Jun 2024
Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
K232893 · Contec Medical Systems Co.,Ltd · Jun 2024
Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
K220245 · Contec Medical Systems Co.,Ltd · Sep 2022
Fetal Doppler
K212084 · Shenzhen Mericonn Technology Co., Ltd. · Nov 2021